BIOBEHAVIORAL INTERVENTIONS FOR ORAL PAIN AND MUCOSITIS

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Oral pain and mucositis are highly prevalent treatment side effects in cancer patients receiving autologous stem cell transplants of marrow or peripheral blood origin. Interventions are needed that address both the underlying mechanisms of mucositis and pain while simultaneously involving the family caregivers who are so important in cancer care The primary aim of this project is to test whether a comprehensive biobehavioral intervention combining misoprostol (a prostaglandin E1 analogue) with psychoeducation that systematically includes family caregivers will reduce severity of oral tissue injury and associated acute oral pain and increase adherence to oral care and pain management standards of care. The secondary aim is to analyze and compare selected costs (pain medications, nutritional support and prolonged hospital stay or readmission due to mucositis) in patients receiving misoprostol plus psychoeducation, misoprostol alone, and usual care. An experimental design will be conducted at the transplant centers of Emory University and the University of Pennsylvania. Consenting patients will be randomly assigned to usual care, misoprostol alone, or misoprostol plus psychoeducation. Mucositis, pain, adherence to oral care and pain management standards, and other relevant data will be collected prior to transplant and at five timepoints afterward until 11 days post-transplant. The study should help delineate the efficacy of a comprehensive intervention that incorporates family caregivers and lead to development of cost-effective models for managing symptoms that prepare patients and family caregivers for home management and undergoing complex medical therapies.